UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040963 |
|---|---|
| Receipt number | R000046778 |
| Scientific Title | Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/07/08 15:16:41 |
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Basic information
Public title
Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Acronym
Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Scientific Title
Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Scientific Title:Acronym
Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Acute respiratory distress syndrome, and severe respiratory or circulatory failure
Classification by specialty
| Pneumology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and describe the safety and complication of intrahospital transport in critically ill patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events
Key secondary outcomes
Death and serious complications (life-threatening) adverse events
The period of of ICU stay
The period of of in hospital stay
Minor adverse events
Costs
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adults, 18 years old or older
2) Patients with intrahospital transfer during ICU stay
3) patients with ICU admission from other units (emergency department, operation rooms or general wards, etc)
Key exclusion criteria
1) Patients with missing outcomes
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Murata |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
murama@muc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Murata |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
Homepage URL
murama@muc.biglobe.ne.jp
Sponsor or person
Institute
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine and Public Health, Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4646
murama@muc.biglobe.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
not released
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1016/j.ajem.2021.11.021
Number of participants that the trial has enrolled
1898
Results
A total of 12,313 intrahospital transports and 1898 patients from 24 studies were included in the meta-analysis. Among 24 studies that evaluated the primary outcome, the pooled frequency of all adverse events was 26.2% (95% CI: 15.0-39.2) and the heterogeneity among these studies was high (I2 = 99.5%). The pooled frequency of death due to intrahospital transport and life-threatening adverse events was 0% and 1.47% each, but heterogeneity was also high.
Results date posted
| 2022 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable due to SR
Participant flow
Not applicable due to SR
Adverse events
Not applicable due to SR
Outcome measures
Not applicable due to SR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 15 | Day |
Other
Other related information
[Database]
MEDLINE, CENTRAL, etc
Observational studies written in English are included.
[Data extraction and management/Assessment of risk of bias]
Two review authors will independently extract data from included articles, and assess the risk of bias of them. We will resolve any disagreement through discussion. We will consult a third review author if we disagree each other.
[Meta-analysis]
We will perform a quantitative analysis when studies are not heterogeneous. Random effects models will be used.
[Subgroup analysis]
Age/Treatments/The objective of transfers/The type of diseases
[Sensitivity analysis]
We will assessed the robustness by excluding the studies with high risk of bias.
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046778
